BSc Biology Jobs at BD | Regulatory Affairs Role | Apply Now
Are you looking for BSc Biology Jobs, BD Careers, or exciting Regulatory Affairs Jobs in the medical device industry? BD is hiring for the position of Regulatory Affairs Operations Analyst in Bengaluru, Karnataka. This opportunity is ideal for candidates with experience in regulatory affairs, product registrations, compliance documentation, and medical device regulations. If you are passionate about healthcare innovation and regulatory compliance, this BD Careers opportunity could be the perfect fit for your professional growth.
About the Company
BD is one of the world’s leading global medical technology companies focused on advancing healthcare solutions. The company develops innovative MedTech products and services that improve medical discovery, diagnostics, and healthcare delivery worldwide. With a strong commitment to innovation and quality, BD offers excellent career opportunities in Regulatory Affairs, healthcare operations, and medical technology.
Job Details:
- Job Role: Regulatory Affairs Operations Analyst
- Company: BD
- Location: Bengaluru
- Category: Regulatory Affairs
- Job ID: R-544104
- Region: APAC
Key Responsibilities
- Identify, submit, and maintain regulatory information in Regulatory databases.
- Manage Notification of Change (NoC) in the RIM system.
- Create NoCs, route for region/country impact assessment, track RA project requirements, and complete final RA documentation for project closure.
- Support RIM system changes, including system configuration decisions, workflow design, data migration, and onboarding new users.
- Assess the necessity for submitting a 510(k) application for proposed device changes.
- Prepare internal “Non-Filing Justifications” for changes that do not require a 510(k) submission.
- Assess the necessity for notification to the Notified Body regarding significant changes to CE-marked products.
- Complete, review, and approve documentation to ensure regulatory compliance.
- Coordinate and collect registration information with R&D, Manufacturing, QA, Medical, and other departments.
- Submit regulatory information on products to external databases when necessary.
- Write and update SOPs, work instructions, and policies as required.
- Coordinate and respond to requests for product data and information.
Qualifications
- B.S. degree or higher in a technical discipline.
- Preferred educational backgrounds include computer science, engineering, bioengineering, biology, or chemistry.
- Suitable opportunity for candidates searching for BSc Biology Jobs and Regulatory Affairs Jobs in the healthcare and medical device sector.
Experience Required
- 2–4 years of Regulatory Affairs experience in medical device companies.
- Experience in international product registrations, new product development, and sustaining engineering is preferred.
Skills Needed
Knowledge Requirements
- Working knowledge of 510(k) regulations for medical devices.
- Knowledge of MDD 93/42/EEC.
- Understanding of 21 CFR 820 – Quality System Regulation.
- Familiarity with FDA guidance and regulatory standards.
- Knowledge of material-related regulatory requirements, including Prop 65, CONEG, DOT, IATA, IMO, and OSHA regulations in the US, Europe, and Canada.
Technical & Professional Skills
- Proficiency in Microsoft Word, Excel, and PowerPoint.
- Strong English communication skills, both oral and written.
- Strong project management skills.
- Ability to manage multiple tasks with attention to detail.
- Self-motivated and comfortable working with remote teams.
- Organized and analytical thinking ability.
Candidates searching for BSc Biology Jobs, BD Careers, and Regulatory Affairs Jobs in Bengaluru should not miss this opportunity to work with a leading global medical technology company and build a strong career in regulatory compliance and healthcare innovation.
